NCT07612774 CAPER-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACS
| NCT ID | NCT07612774 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | West China Hospital |
| Condition | Coronary |
| Study Type | INTERVENTIONAL |
| Enrollment | 233 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 233 participants in total. It began in 2026-05-19 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The CAPER-EVO trial is a single-center, randomized, open-label study with blinded endpoint assessment comparing early evolocumab plus standard lipid-lowering therapy versus standard-of-care lipid-lowering therapy in patients with acute coronary syndrome after successful percutaneous coronary intervention. The study will use serial photon-counting coronary computed tomography angiography at baseline and 52 weeks to assess changes in non-culprit coronary plaque burden and stenosis severity. Secondary outcomes include changes in high-risk plaque features, lipid and inflammatory biomarkers, cardiovascular events, and safety outcomes. The trial aims to determine whether early intensive LDL-C lowering with evolocumab can reduce coronary plaque progression and support PCCT-CCTA as a noninvasive tool for monitoring atherosclerotic plaque dynamics.
Eligibility Criteria
Inclusion Criteria: * Age between 40 and 75 years. * Diagnosis of ACS, including ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) or unstable angina (UA). * Successful PCI treatment, with post-procedural TIMI grade 3 flow and residual stenosis \<30%. And with atherosclerotic plaque presence in non-culprit coronary vessels (not attributed to this target event). * Statin therapy: Patients must have received any statin treatment for at least 4 weeks, with an LDL-C level ≥1.8 mmol/L. * Statin-naive patients must have an LDL-C level ≥3.2 mmol/L. * Agreement to complete baseline CTA and laboratory tests within 7 days of enrollment. * Signed informed consent. Commitment to complete 52 weeks of follow-up. Exclusion Criteria: * History of coronary artery bypass grafting (CABG). * History of valve surgery. * History of PCI treatment before the index ACS event * Complex bifurcation lesions (Medina 1,1,1). * Use of PCSK9 inhibitors (e.g., evolocumab, alirocumab) or potent CYP3A4 inhibitors (e.g., itraconazole) within the last 12 months. * Known intolerance to statins, evolocumab, or other investigational drugs related to the study. * Hepatic or renal insufficiency (eGFR \<60 mL/min/1.73m² or ALT/AST \>3 times the upper limit of normal). * Active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus). * Uncontrolled heart failure (NYHA class III-IV) or malignant arrhythmias. * Allergy or intolerance to contrast agents. * Pregnancy or breastfeeding (or plans for pregnancy within the next year). * Life expectancy of less than 1 year (e.g., due to advanced malignancy). * Participation in another interventional clinical trial within the past 3 months.
Contact & Investigator
Yong He
STUDY DIRECTOR
West China Hospital
Frequently Asked Questions
Who can join the NCT07612774 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Coronary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07612774 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07612774 currently recruiting?
Yes, NCT07612774 is actively recruiting participants. Contact the research team at wxy2cd@yeah.net for enrollment information.
Where is the NCT07612774 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07612774 clinical trial?
NCT07612774 is sponsored by West China Hospital. The principal investigator is Yong He at West China Hospital. The trial plans to enroll 233 participants.